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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN ECHO INSULIN DELIVERY DEVICE

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NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN ECHO INSULIN DELIVERY DEVICE Back to Search Results
Model Number N/A
Device Problem Infusion or Flow Problem (2964)
Patient Problems Hyperglycemia (1905); No Code Available (3191)
Event Date 10/01/2017
Event Type  Injury  
Event Description
Case description: this serious spontaneous case from the united states was reported by a consumer as "high blood sugar over 601 mg/dl" with an unspecified onset date, "high a1c around 11%" beginning on (b)(6) 2017, "high ketones tested at home with urine strip" with an unspecified onset date, "pen might not administer the insulin correctly or not giving the correct amount due to the recalled cartridge holder" with an unspecified onset date, "high blood sugars were due to the novopen echo cartridge holder" with an unspecified onset date, and concerned a (b)(6) year-old male patient (age at the time of reporting) who was treated with novopen echo (insulin delivery device) from unknown start date due to "diabetes mellitus", investigation results: name: novopen¿ echo¿, batch number: fvg7458-3. The product was not returned for examination. The complaint has been registered in the novo nordisk complaint handling system. Manufacturer's comment: batch fvg7458-3 is included in recall ((b)(4)) - cartridge holder issue. As the device (novopen¿ echo¿) has not been returned to novo nordisk a/s for investigation and only very limited information regarding the handling of suspected device is available, it is not possible to identify a clear root-cause of the experienced adverse event and thus find similar incidents to the one reported in (b)(4). Evaluation summary: name: novopen¿ echo¿, batch number: fvg7458-3. (b)(4): the product was not returned for examination. The batch documentation was reviewed no abnormalities relating to the observed problem were found.
 
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas). High blood sugar over 601 mg/dl [blood glucose increased], high a1c around 11% [glycosylated haemoglobin increased], high ketones tested at home with urine strip [urine ketone body present], pen might not administer the insulin correctly or not giving the correct amount due to the recalled cartridge holder [incorrect dose administered by device], high blood sugars were due to the novopen echo cartridge holder [device issue]. Case description: this serious spontaneous case from the united states was reported by a consumer (the patients mother) as "high blood sugar over 601 mg/dl" with an unspecified onset date, "high a1c around 11%" beginning on (b)(6) 2017, "high ketones tested at home with urine strip" with an unspecified onset date, "pen might not administer the insulin correctly or not giving the correct amount due to the recalled cartridge holder" with an unspecified onset date, "high blood sugars were due to the novopen echo cartridge holder" with an unspecified onset date, and concerned a male patient born in (b)(6) who was treated with novopen echo (insulin delivery device) from unknown start date due to "diabetes mellitus". Patient's height, weight and body mass index: not reported. Medical history included diabetes mellitus (type and duration unknown). Concomitant products included - novolog penfill (insulin aspart) solution for injection, 100 u/ml, lantus(insulin glargine). It was reported that the pen might not administer the insulin correctly or not giving the correct amount due to the recalled cartridge holder and on an unknown date, the patient experienced blood sugars over 601 mg/dl more than once, high ketones in urine. The patient had high a1c around 11% in (b)(6) 2017. The mother reported the high blood sugars were due to the novopen echo cartridge holder, but confirmed it was not cracked or broken. The patient did not require hospitalization and was being treated at home with non-carbohydrate fluids and treated with novolog injections every three hours with sliding scale. At the time of report, the patient was recovering. Action taken to novopen echo was not reported. The outcome for the event "high blood sugar over 601 mg/dl" was recovering/resolving. The outcome for the event "high a1c around 11%" was recovering/resolving. The outcome for the event "high ketones tested at home with urine strip" was recovering/resolving. The outcome for the event "pen might not administer the insulin correctly or not giving the correct amount due to the recalled cartridge holder" was not reported. The outcome for the event "high blood sugars were due to the novopen echo cartridge holder" was not reported. Company comment: batchfvg7458-3 is included in recall (b)(4)) - cartridge holder issue.
 
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Brand NameNOVOPEN ECHO
Type of DeviceINSULIN DELIVERY DEVICE
Manufacturer (Section D)
NOVO NORDISK A/S, MEDICAL SYSTEMS
hilleroed,
DA
Manufacturer (Section G)
NOVO NORDISK A/S
krogshoejvej 55
bagsvaerd 2880,
DA
Manufacturer Contact
p.o. box 846
plainsboro, NJ 08536
8007276500
MDR Report Key7058486
MDR Text Key258432308
Report Number9681821-2017-00060
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123766
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Remedial Action Recall
Type of Report Initial,Followup
Report Date 11/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/01/2018
Device Model NumberN/A
Device Catalogue Number185459
Device Lot NumberFVG7458-3
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/11/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction Number00000-7/3/17-001-R

Patient Treatment Data
Date Received: 11/27/2017 Patient Sequence Number: 1
Treatment
1) NOVOLOG PENFILL (INSULIN ASPART),; 2) LANTUS (INSULIN GLARGINE).
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